NDC | 0280-4020-36 |
Set ID | 07478020-5ba0-3b67-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Bayer HealthCare LLC. |
Generic Name | |
Product Class | Anti-coagulant |
Product Number | |
Application Number | PART343 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
· hives · facial swelling · asthma (wheezing) · shock
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is
higher if you
● are age 60 or older
● have had stomach ulcers or bleeding problems
● take a blood thinning (anticoagulant) or steroid drug
● take other drugs containing prescription or nonprescription
NSAIDs (aspirin, ibuprofen, naproxen, or others)
● have 3 or more alcoholic drinks every day while using this
product
● take more or for a longer time than directed
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
● an allergic reaction occurs. Seek medical help right away.
● you experience any of the following signs of stomach bleeding
● feel faint ● vomit blood ● have bloody or black stools
● have stomach pain that does not get better
● symptoms get worse or last more than 10 days
● redness or swelling is present
● ringing in the ears or a loss of hearing occurs
● new symptoms occur
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
● fully dissolve 2 tablets in 4 ounces of water before taking
adults and children 12 years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 8 tablets in 24hours adults 60 years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 4 tablets in 24 hours children under 12 years consult a doctor consult a doctor - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ALKA-SELTZER LEMON LIME
alka-seltzer lemon lime tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-4020 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 1000 mg SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 1700 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) DOCUSATE SODIUM (UNII: F05Q2T2JA0) POVIDONE (UNII: FZ989GH94E) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor LEMON Imprint Code Alka;Seltzer;Antacid Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-4020-36 18 in 1 CARTON 11/07/2014 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 11/07/2014 Labeler - Bayer HealthCare LLC. (112117283)